Kornimate/medical-research-clean huggingface dataset:
an observational clinical feasibility study of the magnetic esophageal sphincter

Conditions: Gastroesophageal Reflux Disease

Summary: magnetic esophageal sphincter implant is intended to reinforce esophageal sphincter function in the treatment of gastroesophageal reflux disease (gerd)

the purpose of this feasibility study is to collect preliminary performance and safety information and develop procedural optimization for the torax medical inc. magnetic esophageal sphincter device (mes) in reinforcement of esophageal sphincter function to treat gastroesophageal reflux disease (gerd). the information from this study will be used to support the design and conduct of an expanded clinical trial.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, \ 3yrs. * documented history of gerd symptoms such as heartburn and/or regurgitation. * on daily ppi treatment for at least 3-months. * responsive to ppi treatment. * gerd symptoms, in absence of ppi therapy (minimum 10 days). * ambulatory esophageal ph \< 4 for ≥ 5% time or ph \< 4 for ≥ 3% time in supine position. * patient is a surgical candidate. * patient is willing and able to cooperate with follow-up examinations. * patient has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes (hipaa). exclusion criteria: * the procedure is an emergency procedure. * patient is currently being treated with another investigational drug or investigational device. * patient has had prior gastric or esophageal surgery. * patient has had any previous endoscopic intervention for gerd * patient has suspected or confirmed esophageal or gastric cancer. * patient has any size paraesophageal hiatal hernia or sliding hiatal hernia ≥3cm. (investigator to identify and record type of hiatal hernia at the time of assessment (i.e. para-esophageal, sliding)). * patient's esophageal motility is less than 35 mmhg peristaltic amplitude on wet swallows or \> 30% failed (non-propulsive) peristaltic sequences. * patient has esophagitis - grade b, c, d (la classification). * patient has barretts esophagus. * patient has bmi \> 35. * patient has symptoms of dysphagia or indications of dysphagia from barium esophagram. * patient has scleroderma and/or achalasia. * patient has an esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.). * patient has an electrical implant or metallic, abdominal implant(s). * patient cannot understand trial requirements or is unable to comply with follow-up schedule. * patient is pregnant or nursing, or plans to become pregnant. * patient has a psychiatric disorder.

Keywords: gerd
screening for early diagnosis of nose cancer

Conditions: Nasopharyngeal Carcinoma

Summary: the goal of this clinical trial is to evaluate the effectiveness of screening in identifying nasopharyngeal cancer (npc), and evaluate the performance of epstein-barr virus (ebv) biomarkers in a community screening setting in singapore. participants will assessed for their risk of npc using ebv early antigen (ea) iga serology and cell-free plasma ebv dna. if the initial plasma ebv dna test is positive, a repeat blood sample will be taken and tested. saliva will also be collected for evaluation of ebv risk strains, but not used for risk evaluation. 1. high risk individuals are determined by: * a positive ebv ea iga serology test, and/or * two consecutive positive plasma ebv dna tests high risk individuals will undergo evaluation in the outpatient otolaryngology clinic. the evaluation includes a head and neck examination, nasoendoscopy and nasopharyngeal biopsy. clinical data will be collected at yearly intervals, for at least 3 years, with annual clinical examination and blood tests. 2. low risk individuals are determined by: * a negative ebv ea iga serology, and * a negative plasma ebv dna test, or an initially positive plasma ebv dna test followed by a negative plasma ebv dna test on repeat blood taking. low risk individuals will be contacted via phone call every year for at least 3 years to confirm their disease status. records will also be reviewed at the national registry of disease office, health promotion board, to confirm that the participant has not been diagnosed with nasopharyngeal cancer.


Eligibility criteria:
inclusion criteria: * chinese, malay, and mixed ethnicities * individuals not diagnosed with npc * individuals with family history of npc exclusion criteria: * younger than 35, older than 60 * individuals already diagnosed with npc * pregnant women

Keywords: nasopharyngeal carcinoma community screening ebv iga serology plasma ebv dna
efficacy of stellate ganglion block in traumatic brain injury patients

Conditions: Traumatic Brain Injury

Summary: the goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in traumatic brain injury patients. the main question it aims to answer are: can stellate ganglion block improve the dysphagia and activities of daily living in traumatic brain injury patients. traumatic brain injury patients will be divided into the the control group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

dysphagia, or swallowing difficulty, is a common symptom in traumatic brain injury patients. the goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in traumatic brain injury patients. the main question it aims to answer are: can stellate ganglion block improve the dysphagia and activities of daily living in traumatic brain injury patients. traumatic brain injury patients will be divided into the the control group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, meeting the diagnosis of traumatic brain injury; * presence of no contraindication for stellate ganglion block; * with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications; * informed consent form was obtained from the patient\&#39;s family members, indicating their full understanding of the study and agreement to participate. exclusion criteria: * unable to cooperate in completing treatment and assessment due to personal reasons or other disorders; * complicated with other intracranial lesions, such as stroke; * with severe consciousness disorders caused by other diseases.
risk assessment of mild traumatic brain injury in military training

Conditions: Trauma, Brain

Summary: the sniper-tbi study aims to identify and quantify the risk of mild traumatic brain injury (mtbi) in soldiers of the czech armed forces during specific high-risk training activities, including parachute jumps, high-caliber firearms shooting, artillery blasts, and close quarters battle (cqb) exercises. the study will utilize both diagnostic biomarker analysis and experimental biomechanical measurements to assess the physiological impact of these activities on brain health. the ultimate goal is to reduce mtbi incidence, improve operational readiness, and extend the active service duration of soldiers through targeted preventive measures.

the sniper-tbi study aims to quantify the risk of mild traumatic brain injury (mtbi) in czech armed forces soldiers during high-risk training activities, including parachute jumps, high-caliber firearms shooting, artillery blasts, and close quarters battle (cqb) exercises. the study combines diagnostic biomarker analysis (gfap, uch-l1) and experimental biomechanical measurements using wearable sensors and high-speed cameras. these data will provide critical insights into the forces exerted on the brain during training and help establish exposure limits to minimize long-term neurological impairment. the results will guide the development of protective strategies and enhance soldier readiness.

Eligibility criteria:
inclusion criteria: * age 18-50 years * active-duty military personnel * participating in designated high-risk training activities exclusion criteria: * history of significant brain injury * current neurological disorders * use of anticoagulant medications

Keywords: mtbi biomechanics military training
a multi-dose study with a treatment for open-angle glaucoma

Conditions: Open-Angle Glaucoma

Summary: the purpose of this study is to determine whether anecortave acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * patients at least 18 years old with a clinical diagnosis of open-angle glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication exclusion criteria: * prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

Keywords: open-angle glaucoma intraocular pressure anecortave acetate
relation between bioelectrical impedance analysis (bia) and ct-scan analysis in the icu

Conditions: Muscular Atrophy

Summary: aim of the present study is to determine whether muscle mass as assessed by bioelectrical impedance analysis correlates with and corresponds to muscle mass as assessed by ct scan analysis in critically patients admitted to the intensive care unit.

bia measurements are performed in critically ill patients admitted to the icu or mc, within 72 hours before or after ct scanning. the bia measurements are taken with the bia 101 ase, manufactured by akern, florence-7 italy. this device is phase sensitive and injects an alternating current of 400 µa at 50 khz. measurements were performed while patients lay in supine position with a pillow supporting the head. the resistance, reactance, body weight and length are entered in the bia algorithm, using bodygram pro. this algorithm calculated the body composition, with muscle mass being reported in kilogram (kg). abdominal ct scans are analyzed using the computer program sliceomatic® version 4.3 and 5.0 (tomovision, montreal, qc, canada) at the level of the third lumbar vertebra (l3). the muscle tissue was identified by using boundaries in hounsfield units (grayscale) set of -29 to +150(23). the program computes muscle surface area in cm2, by multiplying the pixel area by the amount of pixels identified as muscle. for a direct comparison with the bia-derived muscle mass, the ct-derived muscle area is converted to kg. this is done by following two steps. firstly, the shen equation is used for the conversion to litres.secondly, the muscle volume is multiplied by its density, resulting in muscle mass expressed in kg.

Eligibility criteria:
inclusion criteria: * abdominal ct-scan made for diagnostic reasons exclusion criteria: * ct-scan not analysable * internal or external metal devices * active pacemaker

Keywords: muscles intensive care tomography, x-ray computed electric impedance
walking, spontaneous physical activity and lipid oxidation after dietary treatment of obesity

Conditions: Obesity

Summary: the purpose of this study is to determine whether walking exercise after dietary treatment of obesity is associated with a decrease of the daily spontaneous physical activity and\\or with an increase of the time spent in sedentary activities. our hypothesis is that the practice of walking as an exercise during the phase of weight stability following the dietary treatment of obesity leads to a reduction of spontaneous physical activity and\\or to an increase in the time spent in sedentary activities.

the subjects of this study will be randomised in 2 groups: a group with usual follow-up and a group with usual follow-up associated with recommendations to introduce a program of walking achieving gradually 2000-2500 kcal/week.

Eligibility criteria:
inclusion criteria: * women from 18 to 50 year-old * in phase of weight stability * bmi\<40kg/m² exclusion criteria: * history of bariatric surgery * diabetes * suspicion of obstructive sleep apnea syndrome

Keywords: obesity weight loss maintenance spontaneous physical activity lipid oxydation walking
diffusion mri (magnetic resonance imaging) using adc (apparent diffusion coefficient) histograms in the evaluation of adnexal tumor aggressiveness

Conditions: Adnexal Tumor

Summary: diffusion-weighted sequences have been routinely performed for years to study the pelvis. they have been so far mainly qualitatively interpreted, that is to say as the absence or presence of an hypersignal at a high b value. the quantitative analysis involves placing the region of interest (roi) on the apparent diffusion coefficient (adc) map. the manual placement is very operator dependent, and does not reflect the entirety of the studied mass. in all fields of magnetic resonance imaging, a multiparametric approach integrating diffusion analysis is flourishing. however, the quantitative analysis of the diffusion is still little studied for tumor heterogeneity analysis, including in the gynecological sphere. the investigators will therefore retrospectively evaluate the apparent diffusion coefficient (adc) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging resonance analysis of adnexal masses and confront the results with the anatomo-pathology results, for patients having undergone surgery, and/or with the clinical and imagery follow-up results. the investigators goal will be to improve the performance of conventional mri in the analysis of adnexal masses. the expected benefits of this study are: * a correlation with the histology analysis or the clinical monitoring * an improved prediction of the malignancy of the tumor * an improved magnetic resonance imaging performance for adnexal masses, with better surgical therapeutic management * an improved negative predictive value, thereby ultimately limiting unnecessary surgical explorations.


Eligibility criteria:
inclusion criteria: - women aged over 18 years old, having undergone magnetic resonance imaging of the pelvis within the chu brugmann hospital. exclusion criteria: * examinations without diffusion sequences * examinations with incomplete diffusion sequences * absence of anato-pathologic result, or absence of gynecological clinical/imaging follow-up.

Keywords: diffusion mri adc histograms adnexal tumor
turkish acute myocardial infarction registry

Conditions: Acute Myocardial Infarction

Summary: there is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (mi) in turkey. turkmi registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute mi in turkey.

background: there is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (mi) in turkey. turkmi registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute mi in turkey. methods: turkmi study, as a nation-wide registry, will be conducted in 50 percutaneous coronary intervention -capable centres selected from each eurostat nuts region in turkey according to their population sampling weight, prioritizing the volume of hospital in each region. all consecutive patients with acute mi admitted to the coronary care units within the 48 hours of symptom onset will be prospectively enrolled during a predefined 2-week period. the first step of the study has cross-sectional design in which baseline information such as symptoms, risk factors, time periods at each step from symptom onset to revascularization, way of arrival to hospital, biochemical analysis and in-hospital management and outcome will be assessed. the second step has a cohort characteristics in which enrolled patients will be followed-up up to 2 years. follow-up visits will be conducted at 1st, 6th, 12th and 24th months, and predictors and risk of cardiovascular events, and implementation of guidelines will be assessed as secondary outcomes. conclusion: the national turkmi registry is expected to provide important information to improve the national policy of the diagnosis, management and outcomes of mi in turkey

Eligibility criteria:
inclusion criteria: 1. having hospitalized within 48 hours of onset of symptoms of the index event 2. had a final (discharge) diagnosis of acute mi either \[st elevation mi (stemi) or non st elevation (nstemi)\] with positive troponin levels, and 3. having signed an informed consent. to facilitate consecutive enrolment, all patients hospitalized at each participating site with acute mi will be recruited consecutively during the same 2 consecutive weeks (15 days). exclusion criteria: 1. patients unwilling or unable to consent will be excluded.

Keywords: acute myocardial infarction mortality registry turkey
compare pharmacokinetic(pk) profiles of xzk vs lovastatin in healthy male volunteers

Conditions: Lipid Metabolism Disorder

Summary: the objective of this study is to compare laboratory tests profiles of a botanic drug xuezhikang (xzk) 300 mg capsules versus a marketed drug lovastatin 20 mg tablets in healthy male volunteers between 18 and 50 years of age.

twenty (20) healthy male subjects will be enrolled and assigned to either xzk group or lovastatin group at a 1:1 ratio at one site in the usa.

Eligibility criteria:
inclusion criteria: * capable of giving informed consent and complying with study procedures; * male subjects between the ages of 18 and 50 years, inclusive; * considered healthy by the pi, based on a detailed medical history, physical examination, clinical laboratory tests, 12-lead ecg and vital signs; * nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening; * body mass index (bmi) of 19 to 32 kg/m2 inclusive and body weight not less than 50 mg; * willing and able to adhere to study restrictions and to be confined at the clinical research center. exclusion criteria: * clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; * history or presence of malignancy other than adequately treated basal cell skin cancer; * clinically relevant illness within one month prior to the screening visit or at screening visit that may interfere with the conduct of this study; * positive blood screen for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c antibody; * a history of seizure. however, a history of febrile seizure is allowed; * a hospital admission or major surgery within 30 days prior to screening; * participation in any other investigational drug trial within 30 days from the last dosing of other trials to screening; * a history of prescription drug abuse, or illicit drug use within 6 months prior to screening; * a history of alcohol abuse according to medical history within 6 months prior to screening; * a positive screen for alcohol, drugs of abuse; * tobacco use within 6 months prior to screening based on subject report; * subjects with hypersensitivity to lipid-lowering agents; * subjects who have participated in a previous clinical study of xzk; * an unwillingness or inability to comply with food and beverage restrictions during study participation; * donation or blood collection of more than 1 unit (approximately 450 ml) of blood (or blood products) or acute loss of blood during the 90 days prior to screening; * use of prescription or over-the-counter (otc) medications, and herbal (including st. john's wort, herbal teas, garlic extracts) within 14 days prior to dosing (note: use of acetaminophen at \< 3g/day is permitted until 24 hours prior to dosing).
prevención en sus manos: feasibility of a novel community-based strategy to improve access to cervical cancer screening

Conditions: HPV

Summary: cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (hpv), and through screening and treatment of cervical disease before it becomes cancet.

primary objectives: the overall purpose of this protocol is to evaluate the feasibility and acceptability of chw-delivered selfsample hpv testing (chw-ss) to increase cervical cancer screening among women in rgv and other low- resource communities in texas. the specific aims of this protocol are to: specific aim 1: determine the feasibility of chw-ss in the rgv and other low-resource communities in texas (i.e., reach, screening uptake, notification of test results). specific aim 2: assess the acceptability and experiences of chw-ss among under screened persons in rural, persistent poverty communities in the rgv and other low-resource communities in texas. secondary objectives: exploratory aim 3: assess attendance for clinical follow-up among individuals who participate in chw-ss and test positive for hr-hpv. exploratory aim 4: evaluate contextual fit of the intervention.

Eligibility criteria:
inclusion criteria: to be eligible to participate in this study, an individual must meet all of the following criteria: * provision of signed and dated informed consent form * currently resident in rgv or other low-resource community in texas * stated willingness to comply with all study procedures * females; age ≥25 years * have no history of hysterectomy with removal of the cervix * have no history of cervical cancer or high-grade dysplasia * have not had a pap test in the past 3.5 years or pap/hpv co-test in the past 5.5 years. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: * unable to communicate in english or spanish * lack valid telephone contact information * report being currently pregnant.